Open Angle GlaucomaPhase 3NCT00901108
Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
A Phase 3 study testing Trabectome-IOL and Trab-IOL in people with Open Angle Glaucoma, run by University of Alberta at 1 site in Canada.
Trial summary
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Trabectome-IOL and Trab-IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Oct 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40-85 years
- Open angle glaucoma (including pseudo exfoliative glaucoma)
- Open angles (≥ Shaffer grade II)
- Inadequately controlled IOP requiring surgical intervention
- Visually significant cataract
- Willing to complete quality of life questionnaires
- Capable of informed consent and available for at least 1 year follow-up
Who cannot join
- Any form of angle closure glaucoma
- Secondary open angle glaucomas
- Absence of clear angle landmarks on gonioscopy
- Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
- Previous angle surgery or filtering procedure
- Steroid use within the preceding 3 months
- Presence of significant co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
Read the detailed description
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma (OAG). Trab MMC has been shown to effectively lower IOP, however, it can be associated with a number of serious complications, such as hypotony maculopathy, choroidal effusion or hemorrhage, and endophthalmitis, as well as less serious complications that may affect vision related quality of life such as bleb dysesthesia.
A newer technology, referred to as the Trabectome (NeoMedix Corp., San Juan Capistrano, CA), removes an arc of trabecular meshwork and inner wall of Schlemm's canal with microcautery and appears to lower IOP effectively with fewer and less serious complications than Trab MMC. However, more studies are needed to determine the long term safety and efficacy of this relatively new procedure.
In addition, for OAG patients with visually significant cataracts, either Trab MMC or Trabectome can be combined with cataract surgery.
Study Objective: To compare the efficacy and safety of Trabectome versus Trab MMC, in combination with cataract extraction by phacoemulsification and intraocular lens implant, for control of IOP in OAG, including pseudoexfoliative glaucoma.
Methods: Single center, single surgeon, prospective randomized controlled trial. A total of 52 eligible participants, 26 per study arm would need to be recruited for 90% power. One eye per study patient will be enrolled and randomized to Trabectome combined with cataract surgery (Trabectome-IOL) or Trab MMC combined with cataract surgery (Trab-IOL).
Postoperative visits will take place at the discretion of the surgeon but will include at least visits at day 1, week 1, and months 1, 3, 6, and 12. Postoperative glaucoma medications will be added in a stepped regimen as appropriate, along with additional laser or surgical procedures if needed.
Current Study Status: The clinical trial was terminated early due to slow recruitment and clearer indications for each technique over time leading to lack of clinical equipoise essential for patient randomization/recruitment. This had been discussed and agreed upon with our data safety monitoring board. A total of 19 participants were recruited with followup to one year. Study analysis is pending.
- Conditions
- Open Angle Glaucoma
- Being tested
- Trabectome-IOL, Trab-IOL
- Keywords
- open angle glaucoma, trabectome, trabeculectomy, cataract
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trabectome-IOLProcedure or surgery
Trabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways.
Trabectome will be done first, followed by cataract surgery because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery.
Trab-IOLProcedure or surgery
Trabeculectomy bypasses the normal aqueous outflow channels of the eye and creates an external filtration pathway (called a filtering bleb) for aqueous to drain and be reabsorbed back into the circulation. Mitomycin C is an agent used during this procedure to decrease scar formation around the new passage.
Cataract surgery will be done first, followed by Trabeculectomy with Mitomycin C.
| Study group | Role | What they receive |
|---|---|---|
| Trabectome-IOL | Active comparator | Combined Trabectome and cataract extraction with intraocular lens insertion Receives: Procedure: Trabectome-IOL |
| Trab-IOL | Active comparator | Combined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion Receives: Procedure: Trab-IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean IOP at 6 months
Measured: 6 months
Surgical complication rates
Measured: intraoperative and postoperative up to 12 months
Secondary outcomes (6)
Mean difference in IOP from baseline to 6 months
Measured: 6 months
Mean IOP at 12 months
Measured: 12 months
Quality of life measures
Measured: preoperative and postoperative at 6 and 12 months
Mean number of glaucoma medications
Measured: 12 months
Visual acuity
Measured: 12 months
Need for additional laser (excluding suture lysis) and surgical interventions
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startNov 2009
- Primary completionApr 2015
- Study completionOct 2015
Why it stopped: Slow study recruitment and lack of clinical equipoise over time
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karim Damji, University of Alberta
- Investigators
- Karim F Damji, MD FRCSC MBA, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00901108
- Sponsor's protocol ID
- UAKD-001
- Status last verified
- Feb 2016
- First submitted
- 11 May 2009
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hu K, Shah A, Virgili G, Bunce C, Gazzard G. Ab interno trabecular bypass surgery with Trabectome for open-angle glaucoma. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011693. doi: 10.1002/14651858.CD011693.pub3.
PubMed 33580495Hu K, Gazzard G, Bunce C, Wormald R. Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD011693. doi: 10.1002/14651858.CD011693.pub2.
PubMed 27526051
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Trial of Trabectome Versus Trabeculectomy With Mitomycin C in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT00901108
- Acronym / sponsor ID
- UAKD-001
- Conditions
- Open Angle Glaucoma
- Keywords
- open angle glaucoma, trabectome, trabeculectomy, cataract
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow study recruitment and lack of clinical equipoise over time
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Apr 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 13 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy and safety of Trabectome versus Trabeculectomy with adjunctive Mitomycin C, combined with cataract surgery, in patients with open angle glaucoma.
Detailed description
Background: Trabeculectomy with adjunctive use of Mitomycin C (Trab MMC) is the standard incisional procedure to lower intraocular pressure (IOP) in adults with open angle glaucoma (OAG). Trab MMC has been shown to effectively lower IOP, however, it can be associated with a number of serious complications, such as hypotony maculopathy, choroidal effusion or hemorrhage, and endophthalmitis, as well as less serious complications that may affect vision related quality of life such as bleb dysesthesia.
A newer technology, referred to as the Trabectome (NeoMedix Corp., San Juan Capistrano, CA), removes an arc of trabecular meshwork and inner wall of Schlemm's canal with microcautery and appears to lower IOP effectively with fewer and less serious complications than Trab MMC. However, more studies are needed to determine the long term safety and efficacy of this relatively new procedure.
In addition, for OAG patients with visually significant cataracts, either Trab MMC or Trabectome can be combined with cataract surgery.
Study Objective: To compare the efficacy and safety of Trabectome versus Trab MMC, in combination with cataract extraction by phacoemulsification and intraocular lens implant, for control of IOP in OAG, including pseudoexfoliative glaucoma.
Methods: Single center, single surgeon, prospective randomized controlled trial. A total of 52 eligible participants, 26 per study arm would need to be recruited for 90% power. One eye per study patient will be enrolled and randomized to Trabectome combined with cataract surgery (Trabectome-IOL) or Trab MMC combined with cataract surgery (Trab-IOL).
Postoperative visits will take place at the discretion of the surgeon but will include at least visits at day 1, week 1, and months 1, 3, 6, and 12. Postoperative glaucoma medications will be added in a stepped regimen as appropriate, along with additional laser or surgical procedures if needed.
Current Study Status: The clinical trial was terminated early due to slow recruitment and clearer indications for each technique over time leading to lack of clinical equipoise essential for patient randomization/recruitment. This had been discussed and agreed upon with our data safety monitoring board. A total of 19 participants were recruited with followup to one year. Study analysis is pending.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trabectome-IOL | Active comparator | Procedure: Trabectome-IOLCombined Trabectome and cataract extraction with intraocular lens insertion |
| Trab-IOL | Active comparator | Procedure: Trab-IOLCombined Trabeculetomy with Mitomycin C and cataract extraction with intraocular lens insertion |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 40-85 years
- Open angle glaucoma (including pseudo exfoliative glaucoma)
- Open angles (≥ Shaffer grade II)
- Inadequately controlled IOP requiring surgical intervention
- Visually significant cataract
Key exclusion criteria (7 listed)
- Any form of angle closure glaucoma
- Secondary open angle glaucomas
- Absence of clear angle landmarks on gonioscopy
- Other ocular disease that may affect assessments of visual acuity, visual field, or accurate tonometry
- Previous angle surgery or filtering procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trabectome-IOLTrabectome removes an arc of trabecular meshwork and inner wall of Schlemm's canal to enhance aqueous outflow through natural drainage pathways. Trabectome will be done first, followed by cataract surgery because Trabectome requires a clear view through the cornea using a goniolens, and this view may be compromised after cataract surgery. | Procedure or surgery | Trabectome-IOL |
| Trab-IOLTrabeculectomy bypasses the normal aqueous outflow channels of the eye and creates an external filtration pathway (called a filtering bleb) for aqueous to drain and be reabsorbed back into the circulation. Mitomycin C is an agent used during this procedure to decrease scar formation around the new passage. Cataract surgery will be done first, followed by Trabeculectomy with Mitomycin C. | Procedure or surgery | Trab-IOL |
Primary outcome
Mean IOP at 6 months
Time frame: 6 months
Surgical complication rates
Time frame: intraoperative and postoperative up to 12 months
6 secondary outcomes
Mean difference in IOP from baseline to 6 months
Time frame: 6 months
Mean IOP at 12 months
Time frame: 12 months
Quality of life measures
Time frame: preoperative and postoperative at 6 and 12 months
Mean number of glaucoma medications
Time frame: 12 months
Visual acuity
Time frame: 12 months
Need for additional laser (excluding suture lysis) and surgical interventions
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Slow study recruitment and lack of clinical equipoise over time). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Derived from this study: PubMed 33580495Hu K, Shah A, Virgili G, Bunce C, Gazzard G. Ab interno trabecular bypass surgery with Trabectome for open-angle glaucoma. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011693. doi: 10.1002/14651858.CD011693.pub3.
- Derived from this study: PubMed 27526051Hu K, Gazzard G, Bunce C, Wormald R. Ab interno trabecular bypass surgery with Trabectome for open angle glaucoma. Cochrane Database Syst Rev. 2016 Aug 15;(8):CD011693. doi: 10.1002/14651858.CD011693.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karim F Damji, MD FRCSC MBA principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trabectome-IOL and Trab-IOL in people with Open Angle Glaucoma, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow study recruitment and lack of clinical equipoise over time). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean IOP at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00901108, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2016.